Atomoxetine in adults with ADHD: Two randomized, placebo-controlled studies

Atomoxetine in adults with ADHD: Two randomized, placebo-controlled studies
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DOI:
10.1016/s0006-3223(02)01671-2
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发表时间:
2003-01-15
影响因子:
10.6
通讯作者:
Milton, D
Milton, D
中科院分区:
医学1区
文献类型:
--
作者:
Michelson, D;Adler, L;Milton, D

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背景资料:注意力缺陷多动障碍(ADHD)在成人中的研究比在儿童中的研究少,迄今为止报道的治疗研究都是小型的单中心试验。为了评估托莫西汀(一种新型的高选择性去甲肾上腺素转运蛋白抑制剂)的疗效,我们进行了两项大型、多中心治疗试验。方法:两项相同的研究采用随机、双盲、安慰剂对照设计和10周的治疗期,在DSM-IV定义的ADHD成人中进行,根据临床病史进行评估,并通过结构化访谈证实(研究I,n = 280;研究II,n = 256)。主要结果的措施是比较托莫西汀和安慰剂使用重复测量混合模型分析的基线后值的Conners的成人ADHD Rating Scale.Results:在每项研究中,托莫西汀是统计学上上级安慰剂在减少注意力不集中和多动和冲动症状的主要和次要措施评估。托莫西汀患者因不良事件而停药的比例均为10%,两项研究的结果均显示托莫西汀是治疗成人ADHD的有效药物。它缺乏滥用的可能性可能是许多患者的优势。(C)2003生物精神病学学会。
Background: Attention-deficit/hyperactivity disorder (ADHD) has been less studied in adults than in children, and the treatment studies reported to date have been small, single-center trials. To assess the efficacy of atomoxetine, a new, and highly selective inhibitor of the norepinephrine transporter, we conducted two large, multicenter treatment trials.Methods: Two identical studies using randomized, double-blind, placebo-controlled designs and a 10-week treatment period were conducted in adults with DSM-IV-defined ADHD as assessed by clinical history and confirmed by a structured interview (study I, n = 280; study II, n = 256). The primary outcome measure was a comparison of atomoxetine and placebo using repeated measures mixed model analysis of postbaseline values of the Conners' Adult ADHD Rating Scale.Results: In each study, atomoxetine was statistically superior to placebo in reducing both inattentive and hyperactive and impulsive symptoms as assessed by primary and secondary measures. Discontinuations for adverse events among atomoxetine patients were tinder 10% in both studies.Conclusions: Atomoxetine appears to be an efficacious treatment for adult ADHD. Its lack of abuse potential may be an advantage for many patients. (C) 2003 Society of Biological Psychiatry.